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Atezolizumab and Bevacizumab With Combined Radiotherapy for Advanced Hepatocellular Carcinoma
Sponsor: Yonsei University
Summary
Atezolizumab plus Bevacizumab combination therapy (AtezoBev) is well-known 1st-line therapy for advanced hepatocellular carcinoma (HCC). However, there are unmet needs for patients with advanced HCC who do not respond to AtezoBev. External beam radiotherapy (RT) is another well-known locoregional therapy for HCC that induces inflammatory cascade and abscopal effect as a systemic anticancer effect and enhances the effect of AtezoBev. Therefore, the investigators aim to verify the effect of AtezoBev plus RT for advanced HCC through this single-center, prospective phase II one-armed cohort study over three years. This study recruits 51 patients to verify the effect of the intervention. Atezolizumab (1200mg) and Bevacizumab (15mg/kg) are administered to patients once for each cycle at 3-week intervals, and additional radiotherapy for the mass or portal vein tumor thrombosis is performed before second cycle of AtezoBev. The primary endpoint is progression-free survival by using response evaluation with modified RECIST.
Official title: A Single-arm Phase II Trial of Atezolizumab and Bevacizumab With Combined Radiotherapy in Advanced Hepatocellular Carcinoma With Portal Vein Invasion
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
51
Start Date
2023-07
Completion Date
2026-07
Last Updated
2023-06-18
Healthy Volunteers
No
Conditions
Interventions
AtezoBev with combined radiotherapy
Atezolizumab (1200mg) and Bevacizumab (15mg/kg) are administered to patients once for each cycle with 3-week intervals, and additional radiotherapy (iGTV 50-60 Gy, CTV 40Gy, PTV 30Gy / 10Fx) for the mass or portal vein tumor thrombosis is performed before second cycle of AtezoBev.
Locations (1)
Severance hospital
Seoul, South Korea